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Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy (IMAGINE)

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ClinicalTrials.gov Identifier: NCT01832636
Recruitment Status : Completed
First Posted : April 16, 2013
Last Update Posted : August 1, 2016
Sponsor:
Collaborator:
Universidade Federal do Ceara
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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Brief Summary:

Several host factors underlie the pathogenesis of the reciprocal cycle of childhood diarrhea and undernutrition in developing countries. These include intestinal inflammation, mucosal damage, and alterations in intestinal barrier function that lead to malabsorption, growth failure, and heightened susceptibility to recurrent and prolonged episodes of diarrhea. Recent studies from Northeast Brazil demonstrate the benefits of a novel alanyl-glutamine-based oral rehydration and nutrition therapy (Ala-Gln ORNT) in speeding the recovery of damaged intestinal barrier function in cell culture, animal models, patients with AIDS, and underweight children.

Oral supplementation with Alanyl-Glutamine (Ala-Gln; 24g a day for 10 days) improves short-term gut integrity and weight velocity 4 months after therapy in a group of undernourished children from Northeast Brazil. Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy (IMAGINE) is a study designed to answer the following questions: 1) What is the lowest dose of Ala-Gln that improves intestinal barrier function, intestinal inflammation, and nutritional status in children at risk of underweight, wasting, or stunting? 2) What are the mechanisms by which Ala-Gln exerts these benefits?


Condition or disease Intervention/treatment Phase
Malnutrition Environmental Enteropathy Diarrhea Dietary Supplement: Alanyl-Glutamine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy (IMAGINE)
Study Start Date : October 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Alanyl-Glutamine 3g/d
Alanyl-Glutamine orally 3g/day for 10 days
 Dietary Supplement: Alanyl-Glutamine
Alanyl-Glutamine and Glycine doses will be prepared immediately prior to administration by dissolving in formula, milk, or fruit juice. Administration of each dose will be directly observed by a study nurse or health agent.
Other Name: AminoStable (Ajinomoto)
Active Comparator: Alanyl-Glutamine 6g/d
Alanyl-Glutamine orally 6g/day for 10 days
 Dietary Supplement: Alanyl-Glutamine
Alanyl-Glutamine and Glycine doses will be prepared immediately prior to administration by dissolving in formula, milk, or fruit juice. Administration of each dose will be directly observed by a study nurse or health agent.
Other Name: AminoStable (Ajinomoto)
Active Comparator: Alanyl-Glutamine 12g/d
Alanyl-Glutamine orally 12g/d for 10 days
 Dietary Supplement: Alanyl-Glutamine
Alanyl-Glutamine and Glycine doses will be prepared immediately prior to administration by dissolving in formula, milk, or fruit juice. Administration of each dose will be directly observed by a study nurse or health agent.
Other Name: AminoStable (Ajinomoto)
Placebo Comparator: Glycine 12.5g/d
Glycine orally 12.5 g/d for 10 days. This dose is calculated to be isonitrogenous to 12g of Alanyl-Glutamine.
 Dietary Supplement: Alanyl-Glutamine
Alanyl-Glutamine and Glycine doses will be prepared immediately prior to administration by dissolving in formula, milk, or fruit juice. Administration of each dose will be directly observed by a study nurse or health agent.
Other Name: AminoStable (Ajinomoto)


Outcome Measures
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Primary Outcome Measures :
  1. Urinary Lactulose: Mannitol Intestinal Permeability Test [ Time Frame: Urine Collection on Day 1, 10-13, 30-37 ]
    Determine the dose-and time-effect of alanyl-glutamine on intestinal barrier function recovery using the intestinal permeability test, with measurement of the percentage of urinary excretion of lactulose, mannitol and ratio of lactulose:mannitol.


Secondary Outcome Measures :
  1. Fecal Lactoferrin Test [ Time Frame: Fecal sample collected on Day 1, 10-13, 30-37 ]
    To evaluate the effect of time and dose-response of alanyl-glutamine on intestinal inflammation, as measured by qualitative or quantitative testing for fecal lactoferrin in stools of children at risk of undernutrition.

  2. Fecal Cytokine Measurement [ Time Frame: Fecal sample collected on Day 1, 10-13 ]
    To evaluate the effect of alanyl-glutamine on intestinal inflammation, by measuring proinflammatory cytokines interleukin-1, interleukin-8, tumor necrosis factor-alpha (TNF), and regenerating gene 1B (REG1B) in stools of children at risk of undernutrition.

  3. Anthropometry [ Time Frame: Measured and calculated Day 1, 10-13, 30-37, 90-104, 120-141 ]
    To evaluate the time and dose-effect of alanyl-glutamine on short and medium-term nutritional status by evaluating changes in anthropometric measures (z scores) over time: height-for-age, weight-for-age, and weight-for-height.

  4. Fecal Calorimetry [ Time Frame: Fecal sample collected on Day 1, 10-13, 30-37 ]
    To evaluate the effect of time and dose-response of alanyl-glutamine on the intestinal absorption of fat, protein, and carbohydrates, by measurement of fecal energy content by bomb calorimetry.

  5. Metabolomic Profile of Urine [ Time Frame: Collected on Day 1, 10-13, 30-37 ]
    To evaluate the time and dose-effect of alanyl-glutamine on metabolism in children at risk of undernutrition by means of urine metabolomic profile tests.

  6. History of Diarrhea in the Previous Two Weeks [ Time Frame: Day 1, 30-37, 90-104, 120-141 ]
    History of diarrhea in the previous two weeks. A day of diarrhea will be defined as 3 or more looser than normal bowel movements in a 24-hour period. Distinct episodes must be separated by at least 2 days without diarrhea. Duration of episodes will be classified as acute (< 7 days), prolonged acute (>6 and <14 days), or persistent (>13 days).


Eligibility Criteria
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Ages Eligible for Study:   2 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children who are undernourished or at risk of undernutrition, with anthropometric z-scores less than or equal to -1 for one of these parameters: height-for-age, weight-for-age, or weight-for-height.
  2. Children ages 2 months to 5 years old.

Exclusion Criteria:

  1. Children who are exclusively breastfed.
  2. Have participated in another intervention study in the past two years.
  3. Fever greater than 38.8 ° C.
  4. Use of antibiotics.
  5. Systemic disease or other serious medical condition (including, but not limited to meningitis, pneumonia, tuberculosis, and chickenpox).
  6. Children who are unable to ingest, retain or absorb nutritional supplements.
  7. Children whose families plan to move from the study area within the next 6 months.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832636


Locations
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Brazil
Universidade Federal do Ceara
Fortaleza, Ceara, Brazil
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Universidade Federal do Ceara
Investigators
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Principal Investigator: Sean R Moore, MD, MS Cincinnati Children´s Hospital
Principal Investigator: Aldo Lima, MD, PhD Universidade Federal do Ceara
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01832636    
Other Study ID Numbers: CIN001 -"IMAGINE"
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: July 2016
Keywords provided by Children's Hospital Medical Center, Cincinnati:
L-Alanyl-L-Glutamine
Environmental enteric dysfunction
Tropical enteropathy
Additional relevant MeSH terms:
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Intestinal Diseases
Malnutrition
Inflammation
Diarrhea
Pathologic Processes
 Signs and Symptoms, Digestive
Nutrition Disorders
Gastrointestinal Diseases
Digestive System Diseases